LACTIGO (MENTHOL) GEL [LACTIGO, INC.]

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LACTIGO (MENTHOL) GEL [LACTIGO, INC.]
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NDC 72481-101-03
Set ID 849c3601-2bc8-0991-e053-2a91aa0a5e7f
Category HUMAN OTC DRUG LABEL
Packager LactiGo, Inc.
Generic Name
Product Class
Product Number
Application Number PART348
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  • Active ingredient

    Menthol 1.25%

  • Purpose

    Topical analgesic

  • Use

    For the temporary relief of minor aches and pains of muscles and joints.

  • Warnings

    For external use only.

    • Avoid contact with eyes and mucous membranes.
    • If contention worsens, or if symptoms persist for more than 7 days or clear up and occur again within a few days, discontinue use of this product and consult a doctor.
    • Do not apply to wounds or damaged skin.
    • Do not bandage tightly.
  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children to avoid accidental ingestion.

    If swallowed, get medical help or contact a Poison Control Center immediately.

  • Directions

    Adults and children 2 years of age and older: Apply to affected area not more than 3 to 4 times daily.

    Children under 2 years of age: Consult a doctor.

  • Other information

    Store at 15°C to 30°C (59°F to 86°F).

  • Inactive ingredients

    Ethoxydiglycol, glycerine, L-carnosine, magnesium sulfate, phenoxyethanol, water, xanthan gum

  • Questions?

    1-844-522-8446

  • PRINCIPAL DISPLAY PANEL

    label

  • INGREDIENTS AND APPEARANCE
    LACTIGO 
    menthol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:72481-101
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A) (MENTHOL, UNSPECIFIED FORM - UNII:L7T10EIP3A) MENTHOL, UNSPECIFIED FORM12.5 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    MAGNESIUM SULFATE ANHYDROUS (UNII: ML30MJ2U7I)  
    DIETHYLENE GLYCOL MONOETHYL ETHER (UNII: A1A1I8X02B)  
    WATER (UNII: 059QF0KO0R)  
    CARNOSINE (UNII: 8HO6PVN24W)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    Product Characteristics
    Colorwhite (White to off white) Score    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:72481-101-03100 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product03/21/2019
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34803/21/2019
    Labeler - LactiGo, Inc. (116992874)
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